What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?

Friday was “Brexit Day” in the United Kingdom—the last day the UK was a full member of the European Union.  At 11pm London time, the UK entered an 11 month “transition period” that will lead to the full exit on December 31, 2020.  On Wednesday the European Parliament voted overwhelmingly to accept the UK withdrawal agreement, but a lot more negotiations are necessary before a true “deal” is made.

It’s hard to find up-to-date opinions on the internet about exactly what is now going to happen with the FMD in the UK because there are so many older articles that were made obsolete with the rapidly evolving events surrounding Brexit since the idea passed its national referendum in 2016 with a vote of 52% to 48%.  People who wrote articles/essays just gave up trying to keep their postings up-to-date with all the twists and turns, so there is a lot of questionable information out there about where the plan is today. 

For example, an article in the Pharmaceutical Journal, A Royal Pharmaceutical Society Publication, dated one year ago on the day before the FMD was to take effect across the EU—February 9, 2019—quoted the UK Medicines and Healthcare product Regulatory Agency (MHRA) as saying that “… if the UK leaves the EU without a deal, our legal obligations to adhere to the FMD will be removed.”  Certainly that’s true, but my understanding was that the MHRA intended to continue following the FMD requirements voluntarily…much like Switzerland and Norway—both not members of the EU—apparently intend to do.  Norway’s National Medicines Verification System (NMVS) is currently operational.  So is the UK’s, since it was a member of the EU when the FMD went into effect last year, but what’s going to happen next?

Most articles have some dire warnings about what might happen if the UK leaves the EU without a “deal”—a, so-called, “No-deal Brexit”.  So with the European Parliament voting to accept the UK exit proposal last week, does that mean there is a brexit “deal”?  I assume so, but the “deal” is mostly just an agreement to negotiate everything necessary to make the exit graceful by another deadline:  December 31, 2020.  If negotiations are incomplete by that time, the exist will be without a “deal”…apparently.  The negotiating partners could extend the deadline if things aren’t progressing as fast as they wished, but the latest that extension would have to be agreed to is June, 2020.  That’s to avoid any last minute surprise delays.  Prime Minister Boris Johnson says there will not be any need for an extension.  Is he right?  Who knows, but look at the long unexpected chain of events that have occurred up to this point.

I found the best answers on the UK NMVS website (see “EMVS Post Brexit Information”, which was posted just last Tuesday).  SecureMed will continue to remain connected to the EU Hub and operate normally at least through the “implementation period” (through the end of this year).  After that, what happens will depend on the UK/EU negotiations that will establish the “…Future Economic Partnership between the UK and EU which will progress during the Implementation Period.”  That’s exactly what I would expect.  And since significant investments have been made, I expect they will come to an agreement to remain connected as a partner state, as opposed to a Member State. 

But if no overall deal is reached by the end of the year, I assume SecureMed will be disconnected from the European Medicines Verification System (EMVS)…probably at 12:01AM January 1, 2021 GMT.  The European Commission didn’t waste much time removing the UK from the Expert Group ‘Delegated act on safety features for medicinal products for human use’.  I monitor that group and I received an automated notification that the UK had been removed from that group at 11:39pm GMT on Friday.  That’s 39 minutes after the hour of the UK’s departure from the EU.

I hope they work it out.  Can’t we all just get along?

Dirk.

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